Economic Observer reporter Liu Xiaonuo

After five years, COVID-19 vaccine giant returned to the spotlight with the world's first tumor vaccine.

On August 19th, Moderna, an American company, announced the successful clinical trial of its personalized tumor vaccine. The capital market immediately boiled over, with Moderna's stock price rising nearly 138% within a week.

Moderna has rapidly produced the first mRNA COVID-19 vaccine that entered clinical trials during the COVID-19 period, which has verified the mRNA technology. This time, Moderna further validated that mRNA can be used for tumor treatment.

Although called a tumor vaccine, it does not actually prevent tumors in healthy individuals, but is used to prevent recurrence after tumor removal. And due to its unique mechanism, it must be tailored for individual patients, which also means its price may be in the hundreds of thousands of dollars range.

The success across the ocean has led many investors to search for 'China's Moderna'.

In the secondary market, the stock prices of vaccine companies such as CanSino (688185. SH/06185. HK) and Wantai Biotech (603392. SH) have surged. However, practitioners believe that traditional vaccine companies have the basic ability for industrialization, but the production logic of individualized tumor vaccines with "one person, one drug" is not entirely the same as large-scale industrial production. These companies have relatively weak research and clinical accumulation in the field of cancer, and the threshold for transformation is high.

Pharmaceutical companies such as Yunding Xinyao (01952. HK) and Shuidi Pharmaceutical Co., Ltd. (01244. HK) have also laid out mRNA tumor vaccines. They mostly prioritize the route of universal tumor vaccines, mainly because universal vaccines have a price advantage. Now they also need to reassess their individualized approach.

The Chinese companies that have made rapid progress in the development of personalized tumor vaccines are mainly small unlisted companies. Previously, they lacked large-scale data validation and were not favored. Moderna's success has helped them regain favor in the capital market, and the phone calls of these company founders have started ringing incessantly. In their view, the track that had been deserted for years finally welcomed its coming of age ceremony.

Previously, we always had to persuade investors and patients to believe in our approach, and in the future they will come to us, "said a senior executive of a tumor vaccine company.

The fastest progress of personalized tumor vaccines in China is in phase II clinical trials, and respondents speculate that the product may not be approved for market until around 2030.

Market research firm Grand View Research predicts that the global mRNA therapy and vaccine market will grow from approximately $11.7 billion in 2023 to approximately $31.3 billion in 2030. Multiple interviewees pointed out that the market size of mRNA personalized tumor vaccines still needs to be clinically validated in other types of tumors.

Embark on the era of 'one person, one medicine'

The successful clinical trial, codenamed INTerpath-001, included 1137 high-risk stage IIB-IV melanoma patients who underwent complete tumor resection.

For these patients, the standard postoperative adjuvant therapy now is PD-1 inhibitors, such as Merck's flagship product pembrolizumab ("K-drug"). INTerpath-001, on the other hand, combined Moderna's personalized tumor vaccine Intismeran with "K-drug", significantly prolonging the subjects' recurrence free survival and distant metastasis free survival.

Multiple interviewees emphasized that the complete data of the clinical trial still needs to be released at an academic conference before a comprehensive evaluation of key indicators such as risk ratio and overall survival can be conducted.

For reference, the five-year follow-up data from the IIb phase study disclosed by Moderna and Merck in June showed that among 157 high-risk stage III/IV melanoma patients who underwent complete resection, the combination therapy group had a 49% reduced risk of recurrence or death and a 59% reduced risk of distant metastasis or death compared to the "K-drug" monotherapy group.

Large scale Phase III clinical trials are the best validation model. ”Liu Mengru, a practitioner of personalized tumor vaccines, said that "K-drug" is the gold standard for tumor immunotherapy, and most combination therapies are difficult to substantially surpass "K-drug" monotherapy. Moderna is expected to bring a breakthrough this time. Liu Mengru is currently the Chief Medical Officer of Anda Biotechnology, which is one of the earliest companies in China to develop personalized peptide based tumor vaccines.

The core logic of Intismeran and PD-1 inhibitors is similar, both belonging to tumor immunotherapy, which induces the body's own immune cells to attack tumor cells. PD-1 inhibitors are equivalent to releasing the immune brake, while personalized tumor vaccines step on the accelerator for immune cells and are equipped with navigation systems targeting tumor cells.

Compared to "personalized cancer vaccines," using "personalized neoantigen therapy" to refer to drugs like Intiseman would be more accurate. Lu Jinhua, co-founder and chief scientist of Xingchen Biotechnology, pointed out that it completely subverts the methodology of traditional pharmaceuticals.

Individualized neoantigen therapy only truly emerged a decade ago, when Lu Jinhua worked at the Center for Biological Products Evaluation and Research (CBER) under the US Food and Drug Administration (FDA). In April 2012, the FDA met with Catherine J. from Dana Farber, the First Affiliated Hospital of Harvard Medical School, the world's first team to formally propose personalized neoantigen therapy Team Wu. Seeing an unprecedented plan, Lu Jinhua and the others were stunned.

According to Lu Jinhua, the new antigen is only expressed in tumor cells and not in normal cells. If vaccines are developed targeting these antigens, they can accurately kill tumors without attacking normal cells, achieving good safety.

Previous cancer drugs were unable to achieve this. "For example, HER2 antigen is highly expressed in breast cancer cells, but it is also expressed in normal epithelial cells, so HER2 targeted drugs also have a lower chance to attack normal tissues, causing adverse reactions. ”Lu Jinhua said.

Another fundamental difference is that the new antigen vaccine is not a known drug. Previously, drugs and vaccines were known, such as pre produced HPV vaccines that could be used on all patients infected with the same strain of virus. But the new antigen vaccine must be "tailor-made".

Moderna requires the following steps to create an Intismeran: extracting blood samples and tumor biopsy samples from patients; Perform gene sequencing to compare the genetic variations in tumor samples; Analyze and predict up to 34 new antigens with potentially better performance through AI algorithms, and encode them; Finally, design personalized new antigen preparations. The whole process takes about 6 weeks.

Lu Jinhua said that it has fully achieved "individualization". Each patient's genetic mutation and the final screening sequence are different, so each person has their own 'product', and drugs for A cannot be used for B

The initial review work of the Wu team was handed over to the team led by Lu Jinhua, and together they explored the preliminary regulatory framework. In the following year or two, multiple teams emerged and Lu Jinhua had nearly 20 meetings with them. In order to enable the immune system to recognize new antigens, the Wu team adopted a peptide route, and others have also proposed bacteria, viruses, yeast DNA， And mRNA, etc.

In 2015, the Wu team founded Neon company and applied for the world's first individualized new antigen vaccine clinical trial application (IND), which was approved by the team led by Lu Jinhua.

To Lu Jinhua's regret, Neon's clinical trial was not successful, and its fate trajectory was like a shooting star. In 2020, Neon was acquired by another mRNA giant BioNTech. Subsequently, personalized tumor vaccines were overshadowed by Neon's failure for a long time, until Moderna's clinical trial was successful.

On August 24th, Moderna CEO St é phane Bancel announced that they hope Intismeran can be approved in the United States by 2027.

From being a gray faced person to becoming the world's number one

This clinical trial was successful, further validating mRNA technology.

According to Liu Mengru's explanation, mRNA tumor vaccines work like this: after mRNA is translated in the human body, it produces peptides or proteins; Proteins are presented to lymphocytes by antigen-presenting cells (APCs); Lymphocytes will search for and kill tumor cells belonging to this type of gene mutation based on the tumor mutation points presented by mRNA.

Moderna was founded in 2010 with the vision of utilizing mRNA technology to help people navigate through various disease domains.

New technologies inevitably encounter setbacks in the early stages. Lu Jinhua's team has approved multiple clinical trials of Moderna's mRNA virus vaccines, but they have failed one after another. In his impression, despite their strong technical abilities, members of Moderna were a bit embarrassed at the time.

The COVID-19 has verified mRNA and made Moderna become a mRNA giant rapidly.

In 2020, Moderna developed the first COVID-19 vaccine to enter human clinical trials. It was only 63 days from sequence selection to the first administration of Phase I. In December of the same year, it was authorized for emergency use in the United States. Moderna, which had a revenue of only $60 million in 2019, achieved a revenue of $19.263 billion in 2022; With the ebb of COVID-19, its revenue will drop to 1.944 billion dollars in 2025.

In Liu Mengru's opinion, if there was no COVID-19 epidemic, the mRNA vaccine would not be industrialized so quickly; Without the AI wave that will emerge after 2023, people would not be able to fully master personalized tumor vaccines.

The development of Intismeran accelerated significantly after the COVID-19 epidemic. The strategic partnership between Moderna and Merck was reached in 2016; In 2017, Intismeran conducted its first human study; In October 2022, Merck officially announced the joint development and commercialization of Intiseman with Moderna, and the following year, the two parties began working together to promote the INTerpath series of late stage clinical trials.

In addition to the melanoma phase III test, Intismeran also has several non-small cell lung cancer pipelines in the clinical phase III stage, and renal cell carcinoma and bladder cancer have entered the clinical phase II stage. The indications for these pipelines are mainly for the combination of "K drugs", postoperative adjuvant therapy, and prevention of recurrence. Moderna also said that it would try to use Intismeran alone to test in multiple tumor types and disease stages such as melanoma, lung cancer, bladder cancer cancer and kidney cancer.

Moderna is still expanding the use of mRNA drugs and announced in June that it will enter the field of autoimmune diseases; In August, its first mRNA influenza vaccine was approved. St é phane Bancel said that by the end of 2026, they will release data from a late stage study on rare genetic diseases, "targeting children born with certain genetic damage that leads to very serious illnesses.

Searching for 'Moderna of China'

The success of Moderna has led Chinese investors to seek mapping in the secondary market.

On August 20th, several stocks including CanSino (688185. SH/06185. HK), Watson Biosciences (300142. SZ), Zhifei Biosciences (300122. SZ), Baike Biosciences (688276. SH), Kanghua Biosciences (300841. SZ), Wantai Biosciences (603392. SH), and Shiyao Innovation (300765. SZ) all hit the daily limit up.

In the following days, market sentiment declined. On August 25th, many companies have basically fallen back to the level of August 19th.

Most of these enterprises have deployed mRNA vaccines during the COVID-19, and a few have set foot in the field of tumor vaccines, but they are not necessarily personalized tumor vaccines, nor have they entered the clinical phase I.

CanSino's rhabdomyosarcoma vaccine and Bacteroid's universal tumor mRNA vaccine have been approved for IIT (Investigator Initiated Clinical Trial); Watson Biosciences, Zhifei Biosciences, and Wantai Biosciences all mentioned mRNA platforms in their financial reports, but no mRNA tumor vaccine pipeline was found. In May 2026, Li Yunchun, Chairman of Watson Biotech, stated that Watson Biotech is expanding into fields such as tumor vaccines using its established mRNA technology platform.

Traditional vaccine companies have a foundation, but the threshold for transitioning to mRNA tumor vaccines is high. ”Li Shiyu, Chief Technology Officer of Qichen Biotechnology, said. Qichen Biotechnology was established in 2015 and is a company specializing in mRNA nucleic acid drugs. The tumor vaccine pipeline has undergone phase II clinical trials.

Li Shiu believes that some traditional vaccine companies have experience in developing mRNA infectious disease vaccines, and their advantage lies in mastering the hard technical foundation of mRNA synthesis, purification, formulation, and production. However, traditional vaccine companies still face several major barriers:

One is the ability of new antigen mining and AI prediction algorithms, which are modules that are completely unnecessary for infectious disease vaccines; The second is the process and quality control system of individualized production, switching from batch assembly line to customized production of one person, one medicine; Thirdly, clinical competence in tumors requires familiarity with solid tumor immunity, combination therapy design, and tumor clinical endpoint design; Fourthly, it is necessary to adapt the medication regimen and safety management for cancer patients.

Not all companies can accurately select 34 antigens like Moderna. If you can't make the right choice, you can't do it. ”Lu Jinhua believes that this is related to the understanding of tumors or genomes by enterprises, as well as the influence of algorithm and parameter settings.

The pharmaceutical companies that have laid out mRNA tumor vaccines have also received significant attention from the market. On August 20th, Yunding Xinyao closed up 41.43%, while Xingshidi Pharmaceutical Co., Ltd. closed up 56.88%. They have all prioritized the deployment of universal mRNA tumor vaccines, which select multiple shared mutation targets that frequently appear in the same cancer population and develop them into spot products.

Yunding Xinyao stated in its recently released 2026 semi annual report that it has built an AI+mRNA platform. In 2021, Yunding Xinyao launched the mRNA COVID-19 vaccine. At the beginning of 2023, it turned to the mRNA therapeutic tumor vaccine. Its universal tumor associated antigen mRNA vaccine is in clinical phase I, and the individualized tumor vaccine is in IIT (clinical research initiated by researchers), which has not yet entered the clinical trial phase of new drugs.

Xia Fang, the vice president of ThinkPad Pharmaceutical Co., Ltd., told the Economic Observer that in 2021, the COVID-19 will hasten the maturation of the mRNA vaccine track, and they also began to develop AI mRNA and LNP (nano lipid particles, a way of delivering mRNA) platforms by themselves. Prior to this, they had already acquired domestic rights to a peptide tumor vaccine in 2020, and the overseas phase III clinical trial of the drug was nearing completion.

Xia Fang said that the industry has recognized that PD - (L) 1, a single target antibody drug, still has certain limitations in tumor treatment. Therefore, in recent years, the research and development direction of the industry has rapidly shifted to new molecules such as bispecific antibodies and multi antibodies, and even cutting-edge explorations such as "six antibodies" have emerged. Tumor vaccines have the potential to cover more immune pathways and can be combined with the existing core product PD-L1 monoclonal antibody of Sinopharm to form an immune synergy scheme.

Sinopharm currently has two mRNA tumor vaccine pipelines, both of which are universal and in the preclinical stage. The company is currently conducting a comprehensive evaluation of its pipeline promotion strategy and assessing opportunities for the development of personalized mRNA tumor vaccines. ”Xia Fang said.

Li Shiu believes that the success of this clinical trial will drive the development of the entire chain of upstream gene sequencing, new antigen AI algorithms, LNP delivery, and personalized GMP production at the industry level, forcing the industry to solve the practical pain points of long production cycles and high costs of personalized production; It will also promote the regulation of technologies such as personalized antigen activation.

May be listed in China by 2030

Most of the rapidly developing personalized tumor vaccine companies in China are small, unlisted biotech companies.

On the morning of August 20th, Liu Mengru found it suddenly very lively, with Moderna being talked about everywhere. Investors keep calling, and founder Hu Landian is very busy. Founded in 2018, Anda Biology is an innovative enterprise that earlier laid out polypeptide individualized tumor vaccine in China. The core pipeline PCNAT 01 for pancreatic cancer has completed the Sino US IND double report, and has been certified as an orphan drug by FDA. China is about to enter clinical phase II.

Liu Mengru said that from 2010 to 2019, Chinese research teams began exploring personalized tumor vaccines. Early clinical trials conducted domestically were mostly based on IIT, with sample sizes generally less than 100 cases, which limited the confirmatory data in the eyes of investors; Conducting large-scale confirmatory phase III clinical trials at the level of Moderna poses significant challenges to the funding and clinical resources of domestic biotech companies.

After 2020, driven by the popularity of adjacent industries such as mRNA and cell therapy, personalized tumor vaccines also had a good situation. Gradually, the biopharmaceutical industry will enter a capital winter in 2023, and the pace of investment will slow down.

In the second half of 2024, mRNA tumor vaccine star company S-Microorganisms went bankrupt. Prior to this, S-Microorganisms had raised approximately 1.3 billion yuan in financing over the past three years, with investment institutions including Sequoia China and WuXi AppTec (603259. SH/02359. HK). The head of an mRNA company still remembers the investor's questioning, 'Even though the microorganisms have collapsed, do you still make mRNA?'? No mRNA company is thriving! ”

The success of Moderna has warmed up the personalized tumor vaccine industry, and specific products from different routes still need further testing in clinical trials.

Liu Mengru introduced that there are three main technical routes for personalized tumor vaccines: firstly, mRNA vaccines synthesize tumor antigens in vivo to activate immunity; Secondly, dendritic cell (DC) vaccines are administered to patients' immune cells in vitro and then transfused; Thirdly, peptide vaccines directly synthesize mutant peptide segments to stimulate anti-tumor responses.

Among mRNA personalized tumor vaccine companies that are basically on the same route as Moderna, the companies that have entered the Phase I clinical stage are mainly Ruihongdi, which is owned by Xinhe Biotechnology and Hengrui Pharmaceutical (600276. SH/01276. HK). Xinhe Biotechnology told Economic Observer that its XH001 injection has basically completed Phase I clinical research and is currently in the observation stage.

Likang Life Technology is one of the fastest progressing personalized tumor vaccine companies in China. They adopted the mRNA-DC route and the core pipeline LK101 injection was approved for clinical trials in March 2023, with indications covering various advanced solid tumors. They are currently conducting phase II clinical studies in 38 hospitals across the country and have also been approved for IND in the United States.

The fastest progressing peptide route is Newamkin Biologics, whose injectable P01 obtained IND in China and the United States in 2023 for the treatment of various advanced solid tumors, and has entered phase II clinical stage in China.

Thanks to the pilot policy of the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, by 2025, LK101 injection from Likang Life has been successfully implemented at West China Lecheng Hospital of Sichuan University and can be used for a fee in Lecheng. According to the Economic Observation Report, over a hundred patients have received treatment. Subsequently, personalized tumor vaccine products from several other companies were also gradually transformed and applied in Lecheng. In May 2026, after the State Council's "Regulations on the Administration of Clinical Research and Clinical Translational Applications of Biomedical New Technologies" officially came into effect, Lecheng needs to align with the national regulatory framework and has suspended the addition of such translational projects.

According to Liu Mengru's calculations, Moderna's Intismeran has not yet undergone clinical trials in China, and it will take at least 4-5 years for it to be officially launched in China. She also pointed out that Intismeran's first indication is melanoma, and there are not many patients in China. In 2022, there were about 8800 new cases nationwide, so Moderna's willingness to come to China may not be very strong.

In Liu Mengru's view, considering the current pace of domestic research and development and the threshold for Phase III clinical investment, if local personalized tumor vaccine products follow a complete standard registration path, it is highly likely that they will not be approved for market until around 2030. If Chinese companies choose other small indications or rare diseases, they may first attach conditions for listing and then conduct confirmatory tests to achieve earlier listing.

Further verification is still needed

Liu Changnian has served as the director of the Oncology Department at Tianjin Cancer Hospital and is currently a partner at Longpan Investment. He has been paying attention to personalized tumor vaccines, but did not take action due to a lack of confirmation. Individualized tumor vaccines are certainly worth investing in. However, if the price is currently skyrocketing, it is not necessary to squeeze in. Additionally, individualized tumor vaccines also have their limitations - they cannot be considered to have solved cancer

Liu Changnian believes that the indications for personalized tumor vaccines are currently limited, and have only been proven to be suitable for patients who are able to undergo surgery and have no residual symptoms after surgery, for the prevention of cancer recurrence. Tumor vaccines need to activate immune cells for immune killing, and the tumor burden of small lesions is relatively small, resulting in better drug efficacy; But for existing large lesions, tumor vaccines may not be able to solve them.

He also pointed out that generally speaking, only about half of cancer patients can undergo surgery. Patients with metastasis generally cannot undergo surgery and can only receive more conservative treatments such as chemotherapy, targeted therapy, and immunotherapy. Tumor vaccines are not yet applicable to them.

Price is also a key issue.

Liu Changnian believes that the specificity of the "one person, one drug" new antigen tumor vaccine is too strong, and the cost is inevitably high. He is more optimistic about the universal tumor vaccine because of its lower cost; However, it is still unclear whether the generic version can achieve personalized efficacy.

Xia Fang believes that there is academic controversy over the differences between the two routes. The universal tumor vaccine targets shared tumor antigens, and compared to individualized tumor vaccines, there are indeed differences in immunogenicity and anti-tumor precision specificity; But it also has a unique immune regulatory mechanism that is conducive to activating the overall anti-tumor immune response of the body.

What is the market size of personalized tumor vaccines? The head of investor relations at Moderna stated in March 2026 that there is still a multi billion dollar opportunity for adjuvant treatment of melanoma worldwide.

The market size of melanoma in Europe and America is still acceptable, but it is not large in China. But if it is expanded to digestive tract tumors or other tumors, the market will definitely be large, "said Lu Jinhua.

Lu Jinhua believes that Intismeran's current success has some clever aspects in clinical trial design, as melanoma is the most sensitive tumor to immunotherapy and has many gene mutation sites. The sensitivity of different tumors to immunotherapy varies, and it cannot be directly assumed that the success of Intismeran can be extended to other types of tumors. But regardless of the success or failure of subsequent clinical trials, Moderna has pointed out a path for future research and development teams to learn from.

Liu Mengru speculates that there may be overseas cooperation on new antigen tumor vaccines in the future.

China's biotech industry obtained some data through IIT in the early stages, but its own capabilities are limited, and foreign large pharmaceutical companies may see the data to discuss business expansion. The clinical trials of new drugs initiated by Chinese companies account for 30% of the world's total, and we hope that personalized cancer vaccines can also go global with innovative drugs. ”She said.

(Author Liu Xiaonuo)